Aishwarya Jagadale

Currently working on 2 projects:

1. PDH Project: (Specification management system TRU ENOVIA)

2. Self-care RMQ Submission (Raw Material Questionnaire Submissions)

• CON creation and update as per different data bases PCPC (Personal Care Products Council), Cosing, USP, PhEU, Pubchem, etc.
• Create and/or revised Finished products (FG), Raw material (RM) and packaging specification (PC) using client Tru System and updating Raw material specifications for various attributes (Grade, Origin, Mfg Sites).
• Ensured all required information is included in each submission package.
• Maintain data in information system and database (Cloud PC, Live Tracker, and SharePoint site).
• Requesting approval and submission of data for changes in software on regular basis (Concerto system) Develop and monitor global raw material change controls.
• Raw material qualification, raw material phase in and phase out to support plant production, managing technical and non-technical change controls, and specification management with a strong understanding of ICH GCP and CGMP requirements.
• Coordinate and engage with multiple internal departments such as procurement, analytics, and quality assurance, as well as external sites (manufacturers, suppliers, distributors, and so on) to comprehend the change, impact assessment, implementation strategy, and required documents governing the change.
• Filling of RMQ templates that have been designed to collect data for all Chemicals Materials used within the Client Consumer Companies in Products globally. Example: Collection of specific technical, quality, regulatory, and safety-related information to be completed by a Raw Material Supplier about a specific Raw Material.
• Collected Data is subsequently used cross-functionally to evaluate the Raw Material itself (Analytical, Micro, etc.) and/or its use in a particular formula/product (Toxicology, Regulatory, Product Stewardship, etc.) Organizing, attending, and participating in stakeholder meetings.
• Act as the point of contact and communicate project status to respective stakeholders.
• Assist in the development of internal training materials.
• Provide Technical assessment for physical/chemical parameters to ensure compliance to the specification of raw material is in scope to changes in feedstock, composition, evaluating the impact on finish products.
• Created detailed reports summarizing findings related to regulatory compliance issues.
• Created and maintained comprehensive project documentation plans and reports for progress tracking and to inform strategic decision-making.
• Assessed project progress and created project status reports to keep project managers and stakeholders informed.